Topical liquid to ameliorate pain and promote healing of burn-injured skin

Abstract

A novel method and composition is disclosed for treating burn injuries on human skin by promoting healing of the damaged skin. In particular, a topical liquid drug formulation is used to treat burn injuries caused by exposure of the skin to heat (thermal burns), the sun or ultraviolet radiation (sunburn), ionizing radiation (radiation burns), chemicals (chemical burns) and electricity (electrical burns). The topical burn treatment liquid contains clotrimazole as the active pharmaceutical ingredient to promote the healing of the burn damaged skin by reducing the edema, erythema, blistering, pain and other symptoms associated with burns, as well as preventing the spread of the burn damage and promoting healing.

What is claimed is: 
     
       1. A method for ameliorating at least one consequence of burn-injured mammalian skin, the method comprising topically applying to the burn-injured mammalian skin a liquid composition comprising 0.5% w/v clotrimazole as the only active ingredient to treat the burn-injured mammalian skin and at least one excipient, the composition applied to the burn-injured mammalian skin under conditions to ameliorate at least one consequence of the burn injury, the at least one consequence selected from the group consisting of partial thickness deepithelialization, full-thickness necrosis, erythema, edema, eschar formation, blistering, and/or pain. 
     
     
       2. A method for ameliorating at least one consequence of a burn-injured mammalian skin, the method comprising topically applying a liquid composition to an affected area of the burn-injured mammalian skin, the composition comprising clotrimazole as the only active ingredient to treat the burn-injured mammalian skin and containing at least one excipient, the concentration of clotrimazole in the composition ranging between 0.25% w/v to 1% w/v inclusive of the liquid composition, the application performed under conditions to ameliorate at least one consequence of a burn injury, the at least one consequence selected from the group consisting of partial thickness deepithelialization, full-thickness necrosis, erythema, edema, eschar formation, blistering, and/or pain. 
     
     
       3. The method of either  claim 1  or  claim 2  where the burn injury is a thermal burn, and is categorized as a first, a second, or a third degree burn. 
     
     
       4. The method of either  claim 1  or  claim 2  where the excipient is propylene glycol. 
     
     
       5. The method of either  claim 1  or  claim 2  where the at least one excipient renders the liquid composition into a gel or a film-forming liquid. 
     
     
       6. The method of either  claim 1  or  claim 2  where the at least one excipient is selected from the group consisting of propylene glycol, a two-carbon alcohol, a three-carbon alcohol, polyethylene glycol, water, buffered saline, and combinations thereof. 
     
     
       7. The method of  claim 1  or  claim 2  comprising topically applying the composition either directly or indirectly to the affected area of the burn injury. 
     
     
       8. The method of  claim 1  or  claim 2  where the liquid is applied to the affected area of the burn-injured skin by at least one of pouring, dropping, and/or spraying. 
     
     
       9. The method of  claim 1  or  claim 2  where the liquid is applied to a sterile dressing substantially covering the affected area of the burn injury. 
     
     
       10. The method of  claim 1  or  claim 2  where the liquid composition is applied to cover the entire affected area of the burn injury. 
     
     
       11. The method of  claim 1  or  claim 2  where the liquid composition is applied within three hours of the burn. 
     
     
       12. The method of  claim 1  or  claim 2  further comprising repeating the topical application of the liquid composition to the affected area of the burn injury at least daily until the burn injury is substantially healed. 
     
     
       13. The method of  claim 1  or  claim 2  further comprising repeating the topical application of the liquid composition to the affected area of the burn injury from once daily up to four times daily until the burn injury is substantially healed. 
     
     
       14. The method of  claim 1  or  claim 2  where the burn injury is a result of exposure to at least one of fire, boiling water, steam, hot metal objects, hot liquids, hot materials, sun, ultraviolet radiation, abnormal cold, chemicals, poison gas, electricity, and/or ionizing radiation. 
     
     
       15. The method of  claim 1  or  claim 2  where the liquid composition is a viscous liquid that air-dries upon application to the burn-injured skin. 
     
     
       16. The method of  claim 1  or  claim 2  where the conditions result in reduced eschar formation. 
     
     
       17. The method of  claim 1  or  claim 2  where application is direct or indirect and is by drop, spray, or mist. 
     
     
       18. A method for ameliorating at least one consequence of burn-injured mammalian skin, the method comprising topically applying to the burn-injured mammalian skin a composition comprising 0.5% w/v clotrimazole as the only active ingredient to treat the burn-injured mammalian skin in a formulation selected from
 1:4 isopropyl alcohol:propylene glycol (v/v), 
 propylene glycol, or 
 75% ethanol, 15% 1,2-propanediol, 10% water (15:3:2 ethanol:propylene glycol:water), the composition applied to the burn-injured mammalian skin under conditions to ameliorate at least one consequence of the burn injury, the at least one consequence selected from the group consisting of partial-thickness deepithelialization, full-thickness necrosis, erythema, edema, eschar formation, blistering, and/or pain.